| Class 2 Device Recall BD Phoenix NMIC306 Panel | |
Date Initiated by Firm | February 29, 2024 |
Date Posted | March 29, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1398-2024 |
Recall Event ID |
94180 |
510(K)Number | K132674 |
Product Classification |
System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
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Product | BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for bacterial identification and quantitation. |
Code Information |
UDI-DI: (10) 3318700 (17)241107 (30)0025 (01) 30382904492923
Lot Number: 3318700
Exp. Date: 07-NOV-2024 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Co. 7 Loveton Cir Sparks MD 21152-9212
|
For Additional Information Contact | same 410-316-4000 |
Manufacturer Reason for Recall | Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results |
FDA Determined Cause 2 | Under Investigation by firm |
Action | BD issued URGENT: Medical Device Product Correction Product Removal letter on 2/29/24 via courier service via tracked letter and/or e-mail. Letter states reason for recall, health risk and action to take:
1. Immediately inspect your inventory for the specific catalog and lot number listed above. Destroy affected product subject to the recall following your institution s process of destruction.
2. Ensure the contents of this notification are read and understood.
3. Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness.
4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements.
BD will issue product replacements following receipt of the completed Customer Response Form.
Contact: North American Regional Complaint Center
Phone: 1-844-8BD-LIFE (1-844-823-5433)
Say Recall when prompted Mon Fri 8:00am and 5:00pm CT
or
Email: productcomplaints@bd.com
Product Advisory, Recall Questions, Product Complaints, Technical Questions |
Quantity in Commerce | 11,800 eaches |
Distribution | Worldwide distribution - US Nationwide and the countries of AR, BE, CO, IN, JP, PE, PY, SG,
TW, UY.
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = LON
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